Vasopressin Versus Norepinephrine for the Management of Shock After Cardiac Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Vasoplegic syndrome after cardiac surgery is a common complication after cardiac surgery, with negative impact on patient outcomes and hospital costs. Pathogenesis of vasodilatory phenomenon after cardiac surgery remains a matter of controversy. Loss of vascular tone can be partly explained by the depletion of neurohypophyseal arginine vasopressin stores. The investigators hypothesized that the use of arginine vasopressin would be more effective on treatment of shock after cardiac surgery than norepinephrine, decreasing the composite end point of mortality and severe morbidity.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Vasopressin or Norepinephrine in Vasoplegic Shock After Non-cardiac Surgery

NCT03483753

Circulatory Shock Non-cardiac Surgery

WITHDRAWN PHASE2/PHASE3

Inotropic Effects of Vasopressin Versus Noradrenaline In Patients With Vasoplegic Syndrome After Cardiac Surgery

NCT06934798

Vasoplegic Syndrome of Cardiac Surgery

RECRUITING PHASE4

Norepinephrine Weaning Guided by the Hypotension Prediction Index in Vasoplegic Shock After Cardiac Surgery

NCT05922982

Vasoplegia Shock Norepinephrine +1 more

RECRUITING NA

Hemodynamic Effect of Norepinephrine Versus Vasopressin on the Pulmonary Circulation in Cardiac Surgery Patients:

NCT04501861

Cardiac Disease

COMPLETED PHASE3

Vasopressin Deficiency in Hemorrhagic Shock

NCT01107314

Body Response to Trauma

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Shock

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Norepinephrine group

Blinded norepinephrine

Group Type ACTIVE_COMPARATOR

Norepinephrine

Intervention Type DRUG

Blinded Norepinephrine will be started if there is persistent hypotension, characterized by mean arterial pressure \<65 mmHg after fluid replacement

Vasopressin Group

Blinded vasopressin

Group Type ACTIVE_COMPARATOR

Vasopressin

Intervention Type DRUG

Blinded Vasopressin will be started if there is persistent hypotension, characterized by mean arterial pressure \<65 mmHg after fluid replacement.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vasopressin

Blinded Vasopressin will be started if there is persistent hypotension, characterized by mean arterial pressure \<65 mmHg after fluid replacement.

Intervention Type DRUG

Norepinephrine

Blinded Norepinephrine will be started if there is persistent hypotension, characterized by mean arterial pressure \<65 mmHg after fluid replacement

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* need vasopressor support

Exclusion Criteria

* younger than 18 years;
* surgery without cardiopulmonary bypass;
* emergency procedure;
* ascending and descending thoracic aortic procedures;
* left ventricular aneurysm resection; enrollment in another study;
* pregnancy;
* neoplasm;
* Raynaud's phenomenon, systemic sclerosis or vasospastic diathesis;
* severe hyponatremia (Na\<130mEq/L);
* acute mesenteric ischemia;
* acute myocardial infarction;
* cardiogenic shock; and refusal to consent

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No